Cancer Biology & Medicine (Dec 2023)

Real-world effectiveness and safety of goserelin 10.8-mg depot in Chinese patients with localized or locally advanced prostate cancer

  • Nanhui Chen,
  • Zengjun Wang,
  • Ming Chen,
  • Qi Ma,
  • Yi He,
  • Yujie Wang,
  • Xin Li,
  • Mingxing Qiu,
  • Lei Shi,
  • Shaoxing Zhu,
  • Qun Xie,
  • Xiuheng Liu,
  • Benkang Shi,
  • Guowen Lin,
  • Weizhong Yang,
  • Yongbin Liao,
  • Haibin Zhang,
  • Shusheng Wang,
  • Jiexian Li,
  • Shaogang Wang,
  • Lijun Dong,
  • Hui Chen,
  • Jiaju Lu,
  • Yongyi Cheng,
  • Xiaoping Zhang,
  • Lulin Ma,
  • Liqun Zhou,
  • He Wang,
  • Shen Li,
  • Dingwei Ye

DOI
https://doi.org/10.20892/j.issn.2095-3941.2023.0335
Journal volume & issue
Vol. 20, no. 12
pp. 1047 – 1059

Abstract

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Objective: Real-word data on long-acting luteinizing hormone-releasing hormone (LHRH) agonists in Chinese patients with prostate cancer are limited. This study aimed to determine the real-world effectiveness and safety of the LHRH agonist, goserelin, particularly the long-acting 10.8-mg depot formulation, and the follow-up patterns among Chinese prostate cancer patients. Methods: This was a multicenter, prospective, observational study in hormone treatment-naïve patients with localized or locally advanced prostate cancer who were prescribed goserelin 10.8-mg depot every 12 weeks or 3.6-mg depot every 4 weeks with or without an anti-androgen. The patients had follow-up evaluations for 26 weeks. The primary outcome was the effectiveness of goserelin in reducing serum testosterone and prostate-specific antigen (PSA) levels. The secondary outcomes included testosterone and PSA levels, attainment of chemical castration (serum testosterone <50 ng/dL), and goserelin safety. The exploratory outcome was the monitoring pattern for serum testosterone and PSA. All analyses were descriptive. Results: Between September 2017 and December 2019, a total of 294 eligible patients received ≥ 1 dose of goserelin; 287 patients (97.6%) were treated with goserelin 10.8-mg depot. At week 24 ± 2, the changes from baseline [standard deviation (95% confidence interval)] in serum testosterone (n = 99) and PSA (n = 131) were −401.0 ng/dL [308.4 ng/dL (−462.5, −339.5 ng/dL)] and −35.4 ng/mL [104.4 ng/mL (−53.5, −17.4 ng/mL)], respectively. Of 112 evaluable patients, 100 (90.2%) achieved a serum testosterone level < 50 ng/dL. Treatment-emergent adverse events (TEAEs) and severe TEAEs occurred in 37.1% and 10.2% of patients, respectively. The mean testing frequency (standard deviation) was 1.6 (1.5) for testosterone and 2.2 (1.6) for PSA. Conclusions: Goserelin 10.8-mg depot effectively achieved and maintained castration and was well-tolerated in Chinese patients with localized and locally advanced prostate cancer.

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